Night sweats, sudden heat and broken sleep push daily life off balance for millions. A fresh approach could steady the ship.
After a late October green light from US regulators, a non-hormonal pill called Lynkuet promises relief from moderate to severe hot flushes and night sweats. Here is what the approval means, who might benefit, and how safety checks will shape real‑world use in the months ahead.
What the FDA has approved
On 24 October 2025, the US Food and Drug Administration approved Lynkuet (elinzanetant) to treat moderate to severe vasomotor symptoms — hot flushes and night sweats — linked to menopause. Bayer plans a US launch in November 2025.
The Medicines and Healthcare products Regulatory Agency in the UK granted approval in July 2025, preceding regulators in Australia, Canada and Switzerland, which have also now cleared the medicine. In the UK, private prescriptions are already possible, while an NHS decision is pending.
Regulators have backed a non-hormonal option for moderate to severe hot flushes, with US availability slated from November 2025.
How Lynkuet works
Lynkuet is not a hormone therapy. The tablet targets the brain’s thermoregulation circuits by blocking neurokinin-1 and neurokinin-3 receptors. These receptors help govern body temperature stability, which can go awry as oestrogen levels fall during the menopause transition.
By damping down the misfiring temperature signals, the drug aims to cut both how often flushes happen and how intense they feel. Because it avoids oestrogen and progesterone, it may suit women who cannot, or prefer not to, take hormone replacement therapy (HRT).
Who might consider it
- Women with frequent, disruptive hot flushes and night sweats who want a non-hormonal option.
- Those with contraindications to HRT, or who experienced side effects on hormone therapy.
- People seeking a treatment with measurable effects in the first weeks of use.
What the trials showed
FDA approval rests on three Phase III studies — OASIS 1, OASIS 2 and OASIS 3 — involving more than 1,400 women. In OASIS 1 and 2, Lynkuet met co‑primary endpoints by weeks 4 and 12, reducing both the number and the severity of moderate to severe hot flushes.
By week 26, more than 80% of participants on Lynkuet achieved at least a 50% drop in hot‑flush frequency.
These results suggest a relatively quick onset of action with continued benefit over six months. The trials did not rely on hormonal pathways, which matters for women advised to avoid oestrogen or progestogens.
Side effects and cautions
Every medicine has trade‑offs. Reported side effects include headache, fatigue, drowsiness, stomach pain, skin rash, diarrhoea and muscle spasms. Some people experienced daytime impairment linked to central nervous system effects.
- Liver checks: raised liver blood test values occurred; clinicians may order monitoring.
- Pregnancy: do not use during pregnancy due to risk of pregnancy loss.
- Seizure risk: people with a history of seizures may face a higher risk and need careful assessment.
Non‑hormonal does not mean risk‑free: pregnancy, liver health and seizure history need careful review before starting.
Availability and access
Roll‑out differs by country and by healthcare system. Private routes may open earlier than public reimbursement in some places.
| Country/region | Regulator decision | Availability | Notes |
|---|---|---|---|
| United States | FDA approved 24 Oct 2025 | Expected from Nov 2025 | Commercial launch planned by Bayer |
| United Kingdom | MHRA approved Jul 2025 | Private prescription now | NHS timing not yet announced |
| Australia | Approved | Timelines vary | Check local prescribing routes |
| Canada | Approved | Timelines vary | Provincial coverage may differ |
| Switzerland | Approved | Timelines vary | Private access likely first |
How it compares with hormone therapy
HRT remains the most effective option for many women with vasomotor symptoms. It can also support bone health and quality of life. Yet HRT is not suitable for everyone, including some women with a history of certain cancers, blood clots or specific cardiovascular risks. For these groups, a non-hormonal medicine with robust trial evidence fills a clear gap.
Non-hormonal alternatives vary. Some antidepressants, gabapentin and oxybutynin can reduce hot flushes for certain women, but tolerability and effect size differ. Lynkuet brings a mechanism tailored to temperature control, with randomised data showing meaningful reductions in frequency and severity.
What to ask your GP or menopause specialist
- Am I a candidate for a non-hormonal therapy like Lynkuet, or would HRT likely work better for me?
- How often should my liver blood tests be checked once I start?
- What side effects should I watch for in the first month, and when should I stop and call?
- Could my other medicines interact with Lynkuet, especially treatments for sleep, mood or pain?
- What are the practical steps to access it now — private prescription, waiting for public coverage, or alternatives meantime?
Practical expectations and everyday tips
Trial data signal change within weeks. Many women saw fewer flushes by week 4, with further gains by week 12. Keep a simple symptom diary before and after starting to track frequency, intensity and sleep quality. That record helps decide whether to continue, switch dose, or try an alternative.
Medication pairs well with daily strategies. Keep the bedroom cool, dress in breathable layers, cut back on alcohol and spicy food in the evening, and manage caffeine earlier in the day. Short relaxation techniques before bed can soften sudden surges and make wake‑ups shorter.
Costs, coverage and planning
Pricing and insurance coverage will shape real access. Private routes may offer speed, while public reimbursement decisions take time. If you are weighing up options, ask your clinician about short‑term bridging treatments and whether a trial period is sensible while coverage decisions evolve.
Key terms to know
- Vasomotor symptoms: medical term for hot flushes and night sweats.
- Neurokinin receptors: brain targets involved in temperature control; Lynkuet blocks NK1 and NK3.
- Non-hormonal therapy: treatments that act without using oestrogen or progesterone.
Eight in ten patients hitting a 50% reduction by six months offers hope — with careful screening to keep it safe.
If symptoms dominate your days, you have options. Some will prefer HRT after a risk check, while others may opt for a non-hormonal path. The arrival of Lynkuet broadens that choice. A focused conversation about your health history, sleep goals and tolerance for side effects will help decide the next step.
Finally, a nonhormonal option that targets thermoregulation—sounds promising. Did the trials include women with perimenopause too, or strictly post‑menopausal? Also curious how often liver labs are needed after start; monthly at first, then taper? Defintely watching this.